MSAT Global Process Owner for Sterilization Validation QMS

Role Summary

MSAT Global Process Owner for Sterilization Validation QMS

Responsibilities

• The Sterilization Network Leader will serve as technical subject matter expert for the intersection of topics related to all forms of sterilization, VPHP decontamination, and depyrogenation
• The Sterilization Network Leader will drive harmonization throughout the local Lilly sites (e.g., maintain global sterilization forums, ensure global documents are current to industry standard and agency expectations, as well as defining current gaps in global alignment and coordinating gap closure)
• The Sterilization Network Leader will be a TS/MS representative on the global change control board. This responsibility will include seeking alignment across global stewards, sites, and serving as the change control approver.
• The Sterilization Network Leader will be responsible and influential with respect to implementation of external trends and understanding how changes could impact Eli Lilly
• Technical writing and oral communication skills are used daily and the ability to effectively communicate and transfer knowledge to all levels of the organization is essential.
• Establish and maintain the global quality system for Sterilization Validation Programs to drive standardization globally.
• Own the Global Standards, Processes, Practices, Trainings, and implementation tools and ensure they are designed according to regulatory, industry and company expectations.
• Provide governance, lead the implementations of improvement initiatives and foster a robust compliance mindset.
• Ensure processes are executed consistently across the organization and monitor signals to drive continuous improvement.
• Act as the leader and SME to ensure supporting IT applications and analytical tools are configured and maintained to support the business needs and facilitates accurate reporting and analytics.
• Define a common set of global effectiveness and efficiency metrics to drive end-to-end performance.
• Monitor performance metrics, report and provide insights to inform decision making to drive further improvements.
• Develop, lead, mentor and maintain a community of cross-functional SMEs to collaborate on proposed improvements and deepen the knowledge of the associated processes & tools.
• Actively collaborate with enterprise-wide teams on standardized global business processes.
• As the subject matter expert, ensure inspection readiness, directly interact with Health Authorities during inspections and draft responses to observations as needed.

Qualifications

• 10+ years‚Äô experience in the pharmaceutical industry in roles across commercial manufacturing and or quality in a manufacturing, validation, and/or Quality roles supporting aseptic product manufacturing
• 7+ years‚Äô experience in sterilization technologies ‚Äì development of systems, execution and operation of systems and continuous improvement of systems in a highly regulated environment.
• Bachelor‚Äôs degree in Natural Science, Engineering, Pharmacy, or other Life Science-related field.
• Candidate will have previous experience implementing and leading global Sterilization programs
• Strong written and oral communication skills
• Understanding of cGMP‚Äôs, policies, procedures, and guidelines relating to sterilization technologies
• Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate Goals
• Approximately 25% travel

Education

• BS/MS in a biological science (or equivalent work experience) or engineering discipline (Microbiology-preferred, Biology, Chemistry, Mechanical Engineering, Biomedical Engineering, etc.).